Events

Safety Alert for Advanced Perfusion System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1404-158
  • Event Number
    2010EBC-0005399
  • Date
    2014-04-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that it has detected that the manual does not provide a complete and clear description of the response of the centrifugation system of the pump, as well as information about the message "999" and "service of the pump", since these could cause that errors of interpretation by part of the user and potentially adverse events on the patient.

Device

Advanced Perfusion System
  • Model / Serial
    SYSTEM 1
  • Product Description
    Used in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures only when used by an expert perpermist in the operation of TERUMOCARDIOVASCULAR SYSTEMS or similar equipment. Centrifugal pump is used in bypass cardiopulmonary procedures only. The pressure monitoring kit is used with physiological pressure transducers that measure the pressure of fluids in an infusion circuit.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation